LMN-101 in a Campylobacter Human Challenge Model

NCT04182490 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CAM02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, double-blind, placebo-controlled, single dose regimen study of LMN-101 followed by Campylobacter jejuni challenge. Subjects will initially, after documentation of informed consent, begin taking their assigned LMN-101 or placebo regimen three times daily. After two days, subjects will receive the C. jejuni challenge inoculum. Subjects will begin an appropriate antibiotic course upon meeting early treatment criteria or 144 hours following C. jejuni challenge, whichever is earlier. Subjects will be allowed to leave the clinical research facility 3 days after antibiotics, when all symptoms have resolved or are resolving, and have had ≥ 2 consecutive stool cultures ≥ 12 hours apart negative for C. jejuni and are afebrile \> 24 hours prior to release and off antipyretics within 24 hours of discharge. Subjects will continue taking their LMN-101 or placebo regimen three times daily for a total of 14 days. Subjects will be provided a diary card/memory aid and thermometer for at-home monitoring of solicited adverse events through Day 24. Subjects will be seen at research facility for protocol-specified evaluations and will also be contacted by telephone 6 months after challenge.

Conditions

Campylobacter Infections

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Solicited or Unsolicited Adverse Events

  Number of participants with solicited or unsolicited adverse events that received LMN-101 compared to placebo for the protocol-specified duration of collection for each type of adverse event.

  Day 1 to Day 14

Study Arms (2)

3000-mg cohort

ACTIVE COMPARATOR

LMN-101, six 500-mg capsules orally three times daily for 14 days (n=21)

Biological: LMN-101

Placebo cohort

PLACEBO COMPARATOR

Placebo, six 500-mg capsules orally three times daily for 14 days (n=21)

Drug: Placebo

Interventions

LMN-101 BIOLOGICAL

VHH-derived binding protein designed to bind and inhibit FlaA, flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, spirulina biomass

Also known as: Variable heavy chain (VHH) binding protein against flagellin

3000-mg cohort

Placebo DRUG

Identical appearing placebo

Also known as: Corn starch

Placebo cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or non-pregnant female between 18 and 50 years of age, inclusive, at time of informed consent
• Willingness to participate after written informed consent obtained
• Available for all planned clinical visits (for physical examinations, blood draws, and stool collections) and follow-up monitoring (9 or 10 clinic visits and 1 phone interview 6 months post-challenge)
• Agreement to follow the restrictions of the study. Willing and able to follow the study directions and procedures, including the rules and procedures of the clinical research unit.
• Demonstrated comprehension of the protocol procedures including knowledge of Campylobacter illness by passing a written examination (passing grade ≥ 70%).
• General good health, without significant medical illness or abnormal physical examination findings as determined by the PI.
• Laboratory values are Grade 1 or lower using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 as defined below:
• Absolute neutrophil count ≥ 1500/μL
• Lymphocyte count ≥ 800/μL
• Platelet count ≥ 125,000/μL
• Hemoglobin ≥ 13.0 g/dL in males (≥ 11.0 g/dL in females)
• Serum creatinine ≤1.5x ULN
• ALT and/or AST ≤ 1.5x ULN
• Total bilirubin ≤ 1.5x ULN
• Females of childbearing potential must commit to use one of the following highly effective methods of birth control consistently for at least 1 month prior to screening through study completion:

You may not qualify if:

• Significant medical condition or laboratory abnormalities that in the opinion of the Principal Investigator preclude participation in the study.
• History of Covid symptoms or positive Covid test within 2 weeks prior to admission date.
• Alcohol or illicit drug abuse/dependency
• Positive serology results for HIV, HBsAg, or HCV with confirmatory assays.
• Pregnancy or breastfeeding
• Personal or documented family history of Guillain-Barr syndrome or neuromuscular disease; or an inflammatory arthritis such as reactive arthritis, ankylosing spondylitis, or rheumatoid arthritis; inflammatory bowel disease; autoimmune disease; malignancy (not including basal cell carcinoma); any immunocompromising condition; or history of major gastrointestinal surgery.
• Evidence of neurological abnormalities.
• History of reactive arthritis or evidence of inflammatory arthritis on exam.
• Fever within the 2 weeks prior to time of enrollment.
• Evidence of IgA deficiency (serum IgA \< 7 mg/mL or below the limit of detection of assay).
• HLA-B27 positive
• Allergy or prior intolerance to two or more of the following antibiotics: azithromycin, ciprofloxacin, levofloxacin, erythromycin, ampicillin, or amoxicillin/clavulanate.
• Allergy or prior intolerance to spirulina or spirulina products.
• Fewer than 3 stools per week or more than 3 stools per day as the usual frequency.
• History of moderate to serious diarrhea while traveling in a developing country within the last 3 years.

Sponsors & Collaborators

• Lumen Bioscience, Inc.: lead
• Naval Medical Research Center: collaborator
• Pharmaron: collaborator
• University of Maryland: collaborator

Study Sites (1)

Pharmaron

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Campylobacter Infections

Interventions

Starch

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Results Point of Contact

• Title: Senior Medical Director
• Organization: Lumen Bioscience, Inc.

trials@lumen.bio

206-899-1904

Study Officials

• Mohamed Al-Ibrahim, MB,ChB, FACP

  Pharmaron

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical-appearing placebo capsules, pharmacy blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy adults are treated with LMN-101 or placebo followed by an oral challenge of campylobacter to compare the frequency of solicited and unsolicited adverse events in subjects that received LMN-101 compared to placebo.

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: December 2, 2019
• Study Start: February 21, 2022
• Primary Completion: October 4, 2022
• Study Completion: October 4, 2022
• Last Updated: September 25, 2025
• Results First Posted: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)